NCT05314738 · Glaukos Corporation
Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus
What this study is about
Clinical Trial to Evaluate the Safety and effectiveness of Corneal Cross-linking in Subjects with Keratoconus.
View original scientific description
Clinical Trial to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects with Keratoconus.
Interventions
COMBINATION_PRODUCT
NXL Energy 1
Riboflavin drops + NXL System to Total Energy Level 1
COMBINATION_PRODUCT
NXL Energy 2
Riboflavin drops + NXL System to Total Energy Level 2
COMBINATION_PRODUCT
NXL Energy 3
Riboflavin drops + NXL System to Total Energy Level 3
COMBINATION_PRODUCT
Sham Treatment
Sham Drops and No exposure to NXL system
Primary outcome measures
Topography
Time frame: 12 Months
Change in Kmax topography value from baseline
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Provide written informed consent
- Ability to hold gaze sufficiently stable for study testing
- Willingness and ability to follow all instructions and comply with schedule for follow-up visits
- Have a diagnosis of keratoconus
Exclusion criteria
- Known allergy or sensitivity to the test articles or components
- Any disease causing abnormal topography other than keratoconus
- Prior or current ocular condition (other than keratoconus) in the study eye that may predispose the eye for future complications
Where
- Dothan, Alabama
- Teaneck, New Jersey
- Westerville, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 8, 2024 · Source of record for eligibility and locations